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Tigermed-Jyton Supports the Multi-center Clinical Registration Study of the First Modular General Microsurgical Robot in China

Recently, the multi-center clinical registration trial of the first modular general microsurgical robot in China, sponsored by Guangzhou DeepSurgery Medical Instrument Technology Co.,Ltd, (hereafter referred to as “DeepSurgery”), has officially kicked off. Tigermed-Jyton is the selected CRO for this innovative and important study. The first patient enrollment in the country was completed today. This project marks a breakthrough from zero to one in the field of clinical registration studies for microsurgical robots in China and injects new impetus into the innovation of China domestic supreme medical equipment.

Hand-Eye Integration, Multi-Arm Collaboration: FUNZAR Redefines Microsurgical Standards

The “FUNZAR” microsurgical control system, independently developed by DeepSurgery, is the world's first modular general microsurgical robot system. This innovative product has the potential to redefine the standards of microsurgery and provide a new solution for microsurgery under the microscope.

This system integrates multiple innovative technologies, demonstrating excellent performance:

1） Hand-eye integrated operation: A world-first pure digital visual fusion of a dexterous robotic arm with ultra-high magnification capabilities, providing 10-100 times zoom up capability, enabling surgeons to enter a new realm where what can be seen is what can be done.

2） Multi-arm collaboration: A world-first small modular integrated microsystem design with flexible multi-arm configuration, solving the problem of requiring assistant operation for existing microsurgical robots internationally, achieving unassisted microsurgery.

3） Universal configuration: A world-first “Multi-Remote Center of Motion (MRCM)” universal micro-configuration covering various surgical scenarios under the microscope. FUNZAR is the only system globally that includes ophthalmic and non-ophthalmic (micro-reconstruction, plastic surgery, orthopedics, neurosurgery, otolaryngology, head and neck surgery, cardiothoracic surgery, general surgery, urology, gynecology, etc.) surgical scenarios in microsurgery.

（Image source of the “FUNZAR” microsurgical control system: DeepSurgery WeChat Official Account）

Breaking Conventions, Collaborative Efforts: Tigermed-Jyton Reshapes the New Heights of Clinical Research Efficiency

Facing the challenge of being the first of its kind in the country with no similar project experience to draw upon, the Tigermed-Jyton team had to build the clinical protocol from scratch. Through in-depth discussions with medical experts, clinical researchers, and regulatory authorities, the team conducted thorough deliberations on various dimensions, including regulatory compliance, feasibility of implementation, and clinical operability. After multiple rounds of optimization and improvement, a study protocol that combines scientific rigor and practicality was finally formulated. During the project's conduct, all parties worked closely together, swiftly responding to the needs of the sponsor and the center, and completed the SSU work for the leading study site within just 2 months. From the finalization of the protocol to the successful enrollment of the first subject, the entire process took only 2.5 months, demonstrating the team's efficient project execution and resource coordination capabilities.

The rapid progress of this project not only reflects the high level of trust and collaboration between Tigermed-Jyton, the sponsor, and clinical investigators, but also provides a valuable model for the clinical development of complex surgical robot products. Tigermed-Jyton will continue to leverage its solid capabilities in regulatory interpretation, resource integration, and execution experience to help more innovative medical technologies benefit patients as early as possible.

About DeepSurgery

Guangzhou DeepSurgery Medical Instrument Technology Co.,Ltd. (referred to as 'DeepSurgery') is a founding member of the China Microsurgery Association and is dedicated to developing intelligent equipment for microsurgical procedures across all areas. The DeepSurgery Microsurgical Robot Project is a transformation project of the First Affiliated Hospital of Sun Yat-sen University, a 2024 Excellent Medical Achievement in Guangdong Province, one of the eight major advances in the Chinese field of microsurgery in 2024, and entered the clinical validation stage as the first in China and third in the world in 2024.